TY - JOUR
T1 - Stent Placement in Patients With Atherosclerotic Renal Artery Stenosis and Impaired Renal Function A Randomized Trial
AU - Bax, Liesbeth
AU - Woittiez, Arend-Jan J.
AU - Kouwenberg, Hans J.
AU - Mali, Willem P. T. M.
AU - Buskens, Erik
AU - Beek, Frederik J. A.
AU - Braam, Branko
AU - Huysmans, Frans T. M.
AU - Schultze Kool, Leo J.
AU - Rutten, Matthieu J. C. M.
AU - Doorenbos, Cornelius J.
AU - Aarts, Johannes C. N. M.
AU - Rabelink, Ton J.
AU - Plouin, Pierre-François
AU - Raynaud, Alain
AU - van Montfrans, Gert A.
AU - Reekers, Jim A.
AU - van den Meiracker, Anton H.
AU - Pattynama, Peter M. T.
AU - van de Ven, Peter J. G.
AU - Vroegindeweij, Dammis
AU - Kroon, Abraham A.
AU - de Haan, Michiel W.
AU - Postma, Cornelis T.
AU - Beutler, Jaap J.
PY - 2009
Y1 - 2009
N2 - Background: Little is known about the efficacy and safety of renal artery stenting in patients with atherosclerotic renal artery stenosis (ARAS) and impaired renal function. Objective: To determine the efficacy and safety of stent placement in patients with ARAS and impaired renal function. Design: Randomized clinical trial. Randomization was centralized and computer generated, and allocation was assigned by e-mail. Patients, providers, and persons who assessed outcomes were not blinded to treatment assignment. Setting: 10 European medical centers. Participants: 140 patients with creatinine clearance less than 80 mL/min per 1.73 m(2) and ARAS of 50% or greater. Intervention: Stent placement and medical treatment (64 patients) or medical treatment only (76 patients). Medical treatment consisted of antihypertensive treatment, a statin, and aspirin. Measurements: The primary end point was a 20% or greater decrease in creatinine clearance. Secondary end points included safety and cardiovascular morbidity and mortality. Results: Forty-six of 64 patients assigned to stent placement had the procedure. Ten of the 64 patients (16%) in the stent placement group and 16 patients (22%) in the medication group reached the primary end point (hazard ratio, 0.73 [95% CI, 0.33 to 1.61]). Serious complications occurred in the stent group, including 2 procedure-related deaths (3%), 1 late death secondary to an infected hematoma, and 1 patient who required dialysis secondary to cholesterol embolism. The groups did not differ for other secondary end points. Limitation: Many patients were falsely identified as having renal artery stenosis greater than 50% by noninvasive imaging and did not ultimately require stenting. Conclusion: Stent placement with medical treatment had no clear effect on progression of impaired renal function but led to a small number of significant procedure-related complications. The study findings favor a conservative approach to patients with ARAS, focused on cardiovascular risk factor management and avoiding stenting
AB - Background: Little is known about the efficacy and safety of renal artery stenting in patients with atherosclerotic renal artery stenosis (ARAS) and impaired renal function. Objective: To determine the efficacy and safety of stent placement in patients with ARAS and impaired renal function. Design: Randomized clinical trial. Randomization was centralized and computer generated, and allocation was assigned by e-mail. Patients, providers, and persons who assessed outcomes were not blinded to treatment assignment. Setting: 10 European medical centers. Participants: 140 patients with creatinine clearance less than 80 mL/min per 1.73 m(2) and ARAS of 50% or greater. Intervention: Stent placement and medical treatment (64 patients) or medical treatment only (76 patients). Medical treatment consisted of antihypertensive treatment, a statin, and aspirin. Measurements: The primary end point was a 20% or greater decrease in creatinine clearance. Secondary end points included safety and cardiovascular morbidity and mortality. Results: Forty-six of 64 patients assigned to stent placement had the procedure. Ten of the 64 patients (16%) in the stent placement group and 16 patients (22%) in the medication group reached the primary end point (hazard ratio, 0.73 [95% CI, 0.33 to 1.61]). Serious complications occurred in the stent group, including 2 procedure-related deaths (3%), 1 late death secondary to an infected hematoma, and 1 patient who required dialysis secondary to cholesterol embolism. The groups did not differ for other secondary end points. Limitation: Many patients were falsely identified as having renal artery stenosis greater than 50% by noninvasive imaging and did not ultimately require stenting. Conclusion: Stent placement with medical treatment had no clear effect on progression of impaired renal function but led to a small number of significant procedure-related complications. The study findings favor a conservative approach to patients with ARAS, focused on cardiovascular risk factor management and avoiding stenting
M3 - Article
C2 - 19414832
SN - 0003-4819
VL - 150
SP - 840-U41
JO - Annals of Internal Medicine
JF - Annals of Internal Medicine
IS - 12
ER -